NIGHTY NITE- not applicable liquid

Nighty Nite by

Drug Labeling and Warnings

Nighty Nite by is a Homeopathic medication manufactured, distributed, or labeled by Alternative Pharmacy, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Grindelia 6X, 12X, Melatonin 12X, Passiflora Incarnata 6X

INDICATIONS:

May temporarily aid in the enhancement of natural sleep.  

WARNINGS:

• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• Use only as directed. 

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Take 10 drops orally at 7:00 PM and 9:00 PM for sleep or as directed by a health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

May temporarily aid in the enhancement of natural sleep.  

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by: Alternative Pharmacy 

                       29399 Agoura Road, Suite 113

                       Agoura HIlls, CA 91301

                       www.ultimatehomeopathics.com

PACKAGE LABEL DISPLAY:

NIGHTY NITE

HOMEOPATHIC

1 FL OZ ( 30 ml)

INGREDIENTS AND APPEARANCE

NIGHTY NITE 
not applicable liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49304-0020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GRINDELIA HIRSUTULA WHOLE (UNII: C08B09D8UJ) (GRINDELIA HIRSUTULA WHOLE - UNII:C08B09D8UJ)	GRINDELIA HIRSUTULA WHOLE	6 [hp_X]  in 1 mL
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	12 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49304-0020-1	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/05/2014

Labeler - Alternative Pharmacy (139900554)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(49304-0020) , api manufacture(49304-0020) , label(49304-0020) , pack(49304-0020)